CITRANATAL HARMONY 2.1- calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated

Citranatal Harmony 2.1 by

Drug Labeling and Warnings

Citranatal Harmony 2.1 by is a Prescription medication manufactured, distributed, or labeled by Mission Pharmacal Company, Accucaps Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

DESCRIPTION

CitraNatal Harmony ® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed “0797” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)	104 mg	Vitamin B 6 (Pyridoxine HCI)	25    mg
Iron (Carbonyl iron)	29 mg	Folic Acid	1    mg
Vitamin D 3 (Cholecalciferol)	400 |U	Docusate Sodium	50    mg
Vitamin E (d|-alpha tocopheryl acetate)	30 |U	Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)	265    mg

INDICATIONS

CitraNatal Harmony ® is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS

This product is contraindictated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

PRECAUTIONS

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

DOSAGE AND ADMINISTRATION

One capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE

Contact with moisture can discolor or erode the capsule.

HOW SUPPLIED

Bottles of 30 capsules each — NDC 0178–0797–30

To report a serious adverse event or obtain product information, call (210) 696–8400

Please consult your health care provider with any dietary concerns.

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

PRINCIPAL DISPLAY PANEL

CitraNatal Sample Carton
NDC: 0178-0797-06

PRINCIPAL DISPLAY PANEL

CitraNatal Label
NDC: 0178-0797-05

PRINCIPAL DISPLAY PANEL

CitraNatal Starter Pack

PRINCIPAL DISPLAY PANEL

CitraNatal Label
NDC: 0178-0797-30

INGREDIENTS AND APPEARANCE

CITRANATAL HARMONY 2.1 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0797
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	104 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	29 mg

Inactive Ingredients
Ingredient Name	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41)	400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	30 [iU]
PYRIDOXINE (UNII: KV2JZ1BI6Z)	25 mg
FOLIC ACID (UNII: 935E97BOY8)	1 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0)	50 mg
DOCONEXENT (UNII: ZAD9OKH9JC)	265 mg

Product Characteristics
Color	purple (opaque)	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	0797
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0797-05	1 in 1 CARTON	01/21/2013	03/21/2014
1		5 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0178-0797-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2013	03/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/21/2013

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Limited		248441727	manufacture(0178-0797)